To evaluate the efficacy and safety of a 12-week administration of HSK39004 inhalation powder in clinical trial participants with COPD
FEV1/FVC after using bronchodilators is <0.7;
30% of the expected value ≤ FEV1 after using bronchodilators < 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhalation aerosol for 15 to 30 minutes after use.
Screening period NYHA cardiac function grade III/IV (according to the NYHA cardiac function grading standard, see Appendix 1);
Had acute myocardial infarction, unstable angina pectoris/acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;
Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;
Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate > 120 bpm, ventricular tachycardia, bradycardia (ventricular rate < 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF > 450 ms or female QTcF > 470 ms;
Parallel
HSK39004 Dry Powder Inhaler Simulant
DrugHSK39004 Dry Powder Inhaler Simulants, administered via oral inhalation, 1 tablet each time, twice daily
HSK39004 Dry Powder Inhaler-0.75mg
DrugHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve
The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve
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